Study of Safety and Efficiency of the Drug Reamberin® in the Intensive Care of Patients With Acut… (NCT05715723) | Clinical Trial Compass
CompletedNot Applicable
Study of Safety and Efficiency of the Drug Reamberin® in the Intensive Care of Patients With Acute Ethanol Intoxication
Russia296 participantsStarted 2022-09-15
Plain-language summary
Acute ethanol intoxication is the most frequent pathologic condition developing in subjects using alcohol. The severity of disorders in acute alcohol intoxication is determined, first of all, by the quantity of consumed alcohol and the duration of the toxic effect. When toxic doses of alcohol are taken per os, a life-threatening condition develops, which is manifested by consciousness depression and severe metabolism disorders. Reamberin (1.5 % meglumine sodium succinate solution) is an infusion solution with a balanced electrolyte composition and succinic acid, which is recommended for rehydration and detoxication in patients with intoxications of different genesis. The metabolic effect of Reamberin helps restore homeostasis and improve the natural organism detoxication. The investigators suppose that administration of Reamberin to patients with acute ethanol intoxication will make it possible to improve the treatment quality as compared to the standard therapy.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
âś“. Male and female patients aged from 22 to 65 years.
âś“. It is planned to administer one of the following treatment types to the patient, as part of the routine clinical practice:
âś“. Primary diagnosis:
✓. Blood ethanol concentration: 1.5 ‰ (per mille) and more.
âś“. Consciousness depression (Glasgow Coma Score = 6-12)
âś“. Laboratory signs of a shift in the acid-base balance towards metabolic acidosis: base deficit (BE) of venous blood less than -2.2 mmol/l).
âś“. Availability of the written consent of the patient or his (her) legally authorized representative.
Exclusion criteria
âś•. Use of other drugs containing malate or succinate.
âś•. Consciousness depression with Glasgow Coma Score of lower than 6.
âś•. Intoxication with addictive substances and psychotropic drugs.
What they're measuring
1
Difference in the average stay duration at ICU between patient groups.
Timeframe: Up to 2 weeks
2
Difference in the average consciousness recovery duration between patient groups.
Timeframe: Up to 2 weeks
Trial details
NCT IDNCT05715723
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company
âś•. Body weight of less than 50 kg or more than 120 kg.
âś•. Data on the presence of malignant neoplasms.
âś•. Decompensation of chronic pulmonary diseases with the development of respiratory failure of degree II-III as at the time of inclusion in the study.